BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1924814 · Received December 7, 2010

    Report

    Report Number
    3004209178-2010-10260
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 30, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P8600004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A PUMP REFILL SOMETIMES LATE APRIL OR EARLY MAY. THE NURSE THAT FILLED THE PUMP DID NOT GIVE THE PT ENOUGH MEDICATION TO LAST UNTIL THE NEXT REFILL, SO HE RAN OUT. THE PT EXPERIENCED SEVERE WITHDRAWAL WITH SYMPTOMS OF NAUSEA, ANXIETY, AND PAIN. THE PT WAS GIVEN ORAL MORPHINE SULFATE TO HELP REDUCE THE WITHDRAWAL SYMPTOMS UNTIL HE COULD HAVE HIS PUMP REFILLED. THE PAIN PERSISTED, SO AN MRI WAS ORDERED. THE MRI REVEALED THAT A GRANULOMA WAS BEGINNING TO FORM. THE MEDICATION WAS REDUCED. ORAL MEDICATIONS WERE USED TO CONTROL HIS PAIN. THE PUMP IS CURRENTLY FILLED WITH SALINE TO KEEP THE CATHETER OPEN WHILE THE GRANULOMA HEALS. ONCE THE GRANULOMA HAS HEALED, THE DOCTOR WILL DETERMINE WHETHER TO START A MEDICATION REGIMENT AGAIN. THE PT IS DOING FINE CURRENTLY. THE PUMP WAS USED TO DELIVER MORPHINE AT 7.498 MG/DAY, BUPIVICAINE AT 7.498 MG/DAY, AND CLONIDINE AT 274.92 MCG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8711, LOT# J10854R18